Expert Insights On Cell Line Development

1. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

   This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

2. The Latest On CRISPR Deployment In TIL Therapy Development 5/30/2025

   Here’s a quick look at how CRISPR’s emerging as an enhancer to improve TIL pharmacokinetics, efficacy, and tolerability without disrupting production.

3. Will Genome Modifications Define Next-Gen AAV Vectors? 5/20/2025

   AAV vectors composed of naturally occurring capsids are suboptimal. Gentle genetic alterations hold promise for safer, more efficient therapy.

4. Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis 5/6/2025

   Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.

5. Why You Need A Raw Material Control Strategy 4/17/2025

   You should start with the end goal in mind, but the first draft is almost never the last. These living documents should evolve as your team gains process knowledge.

6. Ramping Up GMP-Compliant CAR-NK Manufacturing At Scale With iPSCs 4/15/2025

   The ability to produce billions of NK cells in a single production run represents a transformative shift in the economics and logistics of cell therapy.

7. 4 Key Solid Tumor Therapy Objectives iPSCs Can Help Achieve 4/4/2025

   Induced pluripotent stem cells offer some key biologic, technical, and financial advantages over more established PBMC-derived therapies.

8. New Reference Standards To Support Quality of AAV Raw And Starting Materials 1/31/2025

   The United States Pharmacopeia aims to help gene therapy manufacturers address the challenges that come with complex starting materials like endonuclease and plasmids.

9. Host Cell DNA Impurities: A Unique Challenge For rAAV 1/10/2025

   The potential safety impact of residual hcDNA remains largely unknown, but researchers at UCB are investigating to learn more and mitigate if necessary.

10. A Justification For Using In-Process Controls In Place Of Cleaning Validation 1/9/2025

    This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.